(178 days)
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.
The FloTrac Jr sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac Jr sensor is indicated for use in pediatric patients ≥ 12 years of age.
The Acumen IQ sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.
The VolumeView sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.
The FloTrac, Acumen IQ, and VolumeView sensors are constructed from two disposable pressure transducers that convert a physiological signal (or mechanical pressure) to an electrical signal that is transmitted through the cable to the patient monitor. The sensors have a straight, flow-through design in which fluid is passed directly across the pressure sensor. The sensors are comprised of a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A polycarbonate housing with an integral stopcock at one end, and an integral flush device at the other end, encloses the sensors.
The provided FDA 510(k) summary for the FloTrac, FloTrac Jr, Acumen IQ, and VolumeView sensors does not contain detailed information about specific acceptance criteria and the study that proves the device meets those criteria in the typical format requested for an AI/ML-based medical device.
This document describes a substantial equivalence determination for extravascular blood pressure transducers (sensors) manufactured by Edwards Lifesciences, LLC. The core of the submission is that the subject devices are identical to the predicate devices in terms of intended use, indications for use, and technological characteristics, EXCEPT for changed pressure tubing and IV set component materials.
Therefore, the "study" described here is primarily focused on demonstrating that these material changes do not introduce new safety or effectiveness concerns, rather than validating an AI/ML algorithm's diagnostic performance against established ground truth.
Here's a breakdown based on the provided text, addressing your questions where possible, and noting where the information is not applicable or not present:
Overview of the Device and Study's Focus:
The devices in question are FloTrac, FloTrac Jr, Acumen IQ, and VolumeView sensors, which are intravascular pressure monitoring devices that also work with Edwards' arterial pressure-based cardiac output monitoring hardware. The 510(k) submission (K242909) is for modifications to these existing devices, specifically changes to the pressure tubing and IV set component materials. The premise of the submission is that these material changes do not alter the fundamental performance or safety in a way that would require new clinical performance studies typical for an AI/ML device.
1. Table of Acceptance Criteria and Reported Device Performance
The document states:
- "All testing met the existing predetermined acceptance criteria."
- "Based on the performance testing and the technological characteristics, the FloTrac sensors, Acumen IQ sensors, and VolumeView sensors meet the established performance criteria and are substantially equivalent to the predicate."
However, the specific quantitative acceptance criteria (e.g., accuracy +/- X mmHg, drift
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).